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Sponsored CME Lecture: Immunizaon update with Connental Breakfast ‐Debunking the Myths of Vaccinaons ‐Understanding the Advisory Commiee on Immun‐ izaon Pracces (ACIP) recent recommendaons Stan Grogg, DO Heather Bell, DO

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Name of CME Activity: ACOFP 52nd Annual Convention and Scientific Seminars

Dates and Location of CME Activity: Mar,ch 12-15, 2015, The Cosmopolitan Las Vegas, Nevada Sponsored CME Lecture: update with Continental Breakfast -Debunking the Myths of (Be") -Understanding the Advisory Committee on Immunization Practices (ACIP) recent recommendations (Grogg) Saturday, March 14, 2015 6:30-8:00 am

Name of Faculty/Moderator: Stanley E. Grogg, DO, FACOP, FAAP

DISCLOSURE OF FINANCIAL RELATIONSHIPS WITHIN 12 MONTHS OF DATE OF THIS FORM A. Neither I nor any member of my immediate family has a financial relationship or interest with any proprietary entity producing health care goods or services. '/' B. I have, or an immediate family member has, a financial relationship or interest with a proprietary entity producing health care --p:- goods or services. Please check the relationship(s) that applies. Research Grants Stock/Bond Holdings (excluding mutual funds) --$- Speakers' Bureaus* Employment Ownership Partnership Consultant for Fee Others, please list:

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Slgna'u," ~?~ Date: ••••••••••. Stanley E. Grogg, DO, FACOP, FAAP

Please fax this form to ACOFP at 866-328-1835 or email to [email protected] as soon as possible

Deadline: Monday, January 12, 2015

2/27/2015

Vaccine Myths and Misconceptions

Heather Bell, DO Medical Director of Prevention & SJHS, OK

Disclaimer

• Speakers Bureau for: – Cubist Pharmaceuticals – -Pasteur Division

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Source

• The bulk of this presentation can be found on the IAC website as a comprehensive lecture by Dr. Wexler

Background

• This presentation will provide • Information that addresses common concerns • or misconceptions about vaccination. Concerns and misconceptions of patients, parents, and healthcare professionals will be reviewed. • Links to related evidence-based resources — some are intended as background information for healthcare professionals and others for patients/parents. • Focus will be on often administered by pharmacists, but additional slides will be provided at the end about myths related to childhood vaccination.

2 2/27/2015

Patient Myths

• Parents, patients, and healthcare professionals all have misconceptions about vaccination – More parents are questioning the safety and effectiveness of vaccines. – Your responses to them require knowledge, tact, and time. – Adult patients usually do not know which vaccines are recommended for them, and where or when to get vaccinated. – Healthcare providers can miss opportunities to vaccinate by believing false contraindi- cations and following unnecessary rules.

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MYTH: Thimerosal Causes Autism

• The form of mercury found in thimerosal is ethylmercury (EM), not methylmercury (MM). MM is the form that has been shown to damage the nervous system. • Although no evidence of harm has ever been demonstrated, thimerosal was taken out of vaccines as a precaution and “because it can be” (due to single- dose vials) • Since 2001, with the exception of a few influenza products, thimerosal has not been used as a preservative in any routinely recommended childhood vaccines.

MYTH: Thimerosal Causes Autism − cont’d • Multiple studies have shown that thimerosal in vaccines does not cause autism when comparing children who received thimerosal- containing vaccines and those who received vaccines not containing thimerosal. • Studies of three countries compared the incidence of autism before and after thimerosal was removed from vaccines (in 1992 in Europe and 2001 in the U.S.). There was no decrease in autism with the • switch to thimerosal-free vaccines.

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References

• CDC’s Vaccine Safety Concerns web page www.cdc.gov/vaccinesafety/concerns • IAC’s collection of thimerosal-related resources www.immunize.org/thimerosal • NNii’s Mercury in Vaccines web page www.immunizationinfo.org/issues/thimerosal- mercury • Institute of Medicine reports on thimerosal www.nap.edu/books/030909237X/html and http://books.nap.edu/catalog/10208.html • CHOP Vaccine Education Center’s (VEC’s) “Thimerosal: What you should know” www.chop.edu/export/download/pdfs/articles/vaccine- education- center/thimerosal.pdf • VEC’s “Autism: What you should know” www.chop.edu/export/download/pdfs/articles/vaccine- education- center/autism.pdf • CDC’s “CDC: Immunization Safety and Autism – Thimerosal and Autism Research chart” http://www.cdc.gov/vaccinesafety/00_pdf/CDCStudiesonV accinesandAutism.pdf

MYTH: MMR Causes Autism

• Many large, well-designed studies have found no link between MMR and autism. • Autism usually becomes apparent around the same time MMR is given — no causality proven. • Autism probably has multiple components, including genetics (twin studies).

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MYTH: MMR Causes Autism, cont’d

• MYTH: MMR Causes Autism, cont’d • The 1998 study by Andrew Wakefield that started this concern was based on 12 children who were preselected for study. • In 2004, 10 of the 13 authors of this study retracted the study’s interpretation. • On 2/2/10, the editors of The Lancet retracted the paper following the ruling of the U.K.’s General Medical Council that stated the primary author’s conduct regarding his research was “dishonest” and “irresponsible” and that he had shown a “callous disregard” for the suffering of children involved in his studies. • In January 2011, the BMJ published a series of articles showing Wakefield’s work was not just bad science, but deliberate fraud.

References

• IAC’s “MMR vaccine does not cause autism. Examine the evidence!” www.immunize.org/catg.d/p4026.pdf • IAC’s “Clear Answers & Smart Advice about Your Baby’s Shots” by Ari Brown, MD, FAAP www.immunize.org/catg.d/p2068.pdf • CDC’s “MMR Vaccine” www.cdc.gov/vaccinesafety/Vaccines/MMR/index.html • The Fraud Behind the MMR Scare (IAC web section) www.immunize.org/bmj-deer-mmr-wakefield • IOM Report: “MMR Vaccine and Autism” www.nap.edu/catalog.php?record_id=10101

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MYTH: Giving an infant multiple vaccines can overwhelm the immune system

• Babies begin being exposed to immunological challenges immediately at the time of birth. As babies pass through the birth canal and breathe, they are immediately colonized with trillions of bacteria, which means that they carry the bacteria in their bodies but aren’t infected by them. Healthy babies constantly make antibodies against these bacteria and viruses. • Vaccines use only a tiny proportion of a baby’s immune system’s ability to respond; though children receive more vaccines than in the past, today’s vaccines contain fewer antigens (e.g., sugars and proteins) than previous vaccines. alone contained 200 proteins; the 11 currently recommended routine vaccines contain fewer than 130 immunologic components.

MYTH: It’s better to space out vaccines using an alternative schedule

• Delaying vaccines increases the time children will be susceptible to diseases. – In 2011, there were more than 200 cases of measles reported in the United States. Most of the cases were among or linked to travelers returning from or visiting from other countries. – In 2010, 27,550 cases of pertussis were reported to CDC, and many more cases were undiagnosed. • Requiring many extra appointments for vaccinations increases the stress for the child and may lead to a fear of visits to the clinic. • There is no evidence that spreading out the schedule decreases the risk of adverse reactions.

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MYTH: Natural infection is better than immunization

• Natural infection usually does cause better immunity than vaccination. • However, the price paid for natural disease can include paralysis, permanent brain damage, liver failure, liver cancer, deafness, blindness, , or death.

References

• “Natural Infection vs. Immunization” by , MD www.chop.edu/service/vaccine-education-center/hot- topics/natural-infection-vs-immunization.html • NNii’s “Exposure Parties” www.immunizationinfo.org/exposure_parties.cfm • Photos of people with vaccine-preventable diseases www.immunize.org/photos • Real-life accounts of people who have suffered or died from vaccine-preventable diseases www.immunize.org/reports

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MYTH: Ingredients in Vaccines Are Harmful

• Aluminum – Aluminum is used in some vaccines as an adjuvant— an ingredient that improves the immune response. Adjuvants can allow for use of less antigen. They have been used for this purpose for more than 70 years. – Aluminum is the most common metal found in nature. It is in the air and in food and drink. Infants get more aluminum through breast milk or formula than vaccines. – Most of the aluminum taken into the body is quickly eliminated.

MYTH: Ingredients in Vaccines Are Harmful – cont’d

• Formaldehyde – Formaldehyde is used to detoxify diphtheria and tetanus toxins or to inactivate a virus. – The tiny amount which may be left over from these steps in making vaccines is safe. – Formaldehyde is also found in products like paper towels, mascara, and carpeting. – Humans normally have formaldehyde in their blood streams at levels higher than is found in vaccines.

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MYTH: Ingredients in Vaccines Are Harmful – cont’d

• Miscellaneous – Antibiotics are present in some vaccines to prevent bacterial contamination when the vaccine is made. – Additives such as gelatin, albumin, sucrose, lactose, MSG and glycine help the vaccine stay effective while being stored. – Trying to make vaccines without adjuvants, additives, and preservatives is difficult—these ingredients keep vaccines safe and effective.

References

• VEC’s “Aluminum in Vaccines: What you should know” www.chop.edu/export/download/pdfs/articles/vaccine- education- center/aluminum.pdf • IAC’s “Adjuvants and Ingredients” web section www.immunize.org/concerns/adjuvants.asp • NNii’s “Aluminum Adjuvants in Vaccines” www.immunizationinfo.org/issues/vaccine- components/aluminum- adjuvants-vaccines • AAP’s “Questions and Answers about ” www2.aap.org/immunization/families/faq/vaccineingredien ts.pdf • CDC’s “Vaccine Excipient & Media Summary, by Excipient” www.cdc.gov/vaccines/pubs/pinkbook/downl oads/appendices/B/excipient-table-1.pdf • CDC’s “Vaccine Excipient & Media Summary, by Vaccine” www.cdc.gov/vaccines/pubs/pinkbook/downl oads/appendices/B/excipient-table-2.pdf • IAC’s Package Inserts web section www.immunize.org/packageinserts

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MYTH: Disease Rates Have Dropped Due to Factors Other Than Vaccination

• Better living conditions (less crowded housing, better nutrition, etc.) have had an impact on disease rates. BUT, the only real decrease in a VPD has occurred after the introduction of a vaccine to prevent it. • This is also true for newer vaccines like Hib (1987) and varicella (1995), which were introduced during times of modern hygiene. • When some developed countries (U.K., Sweden, Japan) stopped using DTP vaccine, their pertussis rates jumped dramatically. • Several recent outbreaks of measles, pertussis, and varicella in the U.S. have been traced to pockets of unvaccinated children in states that allow personal belief exemptions. When vaccination • rates go down, disease rates go up.

Measles - United States, 1950-2009

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HiB Vaccine

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References

• CDC’s “Some Common Misconceptions About Vaccination and How to Respond to Them” www.cdc.gov/vaccines/vac-gen/6mishome.htm • CDC’s “What Would Happen If We Stopped Vaccinations?” www.cdc.gov/vaccines/vac- gen/whatifstop.htm • IAC’s “Personal belief exemptions for vaccination put people at risk. Examine the evidence for yourself.” www.immunize.org/catg.d/p2069.pdf • NNii’s “Vaccine Effectiveness” www.immunizationinfo.org/parents/why-immunize

MYTH: Vaccines Are Not Effective • Anti-vaccine websites often set up a straw man argument— claiming that experts say that vaccines are 100% effective, and then showing this is not true. Obviously, no one really claims that vaccines are 100% effective, just as no other drug or medical procedure always works. • Most childhood vaccines are very effective when properly administered and all doses are received according to the recommended schedule. (~80%-100%, depending on vaccine) • Some vaccines recommended for adults are not as effective as the childhood vaccines. One of the reasons is that adults, especially elderly adults, have less robust immune systems and may have a lower protective immune response after vaccination. However, even though these vaccines do not prevent all cases, they still have been shown to provide important protection.

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MYTH: Is Not Effective

• Even though zoster vaccine efficacy decreases with age from 64% in people age 60–69 years to 18% in people age 80 years and older, getting vaccinated significantly reduces the risk of developing post- herpetic neuralgia (PHN) in all age groups. In fact, the most elderly individuals are at the highest risk of PHN, and they are least able to tolerate the condition or the medications used to control pain. • PHN is long-term nerve pain that can last for months, even years, and can interfere with eating and sleeping. For some, the pain has been so severe that it has led to suicide.

References − Zoster

• IAC’s Shingles (Zoster) web section www.immunize.org/zoster • “Herpes zoster vaccine in older adults and the risk of subsequent herpes zoster disease,” JAMA, Jan. 2011 www.ncbi.nlm.nih.gov/pubmed/21224457

14 2/27/2015

MYTH: PPSV Vaccine Is Not Effective

• An estimated 40,000 cases of invasive pneumococcal disease occur annually. Case-fatality rates are high, particularly when disease results in (~30%) or bacteremia (~20%). In addition, pneumococcal pneumonia, often a secondary complication of influenza, results in an estimated 175,000 hospitalizations annually. • PPSV is not intended to be a general “pneumonia vaccine” as people often think; i.e., it does not provide substantial protection against all types of pneumonia (viral and bacterial). However, PPSV is 60–70% effective in preventing serious invasive pneumococcal disease.

References - PPSV

• IAC’s PPSV web section www.immunize.org/pneumococcal-ppsv • ACIP’s “Prevention of Pneumococcal Disease,” April 4, 1997 ftp://ftp.cdc.gov/pub/Publications/mmwr/RR/ RR4608.pdf

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MYTH: Influenza Vaccines Are Not Effective

• At least two factors play important roles in determining the likelihood that will protect a person from influenza illness: – characteristics of the person being vaccinated (such as their age and health) – the similarity or "match" between the influenza virus types in the vaccine and those spreading in the community. • Older people and people with certain chronic illnesses will likely develop less immunity than healthy young adults after vaccination. However, even for these high- risk individuals, the flu vaccine still can provide protection against getting severe complications from the flu.

MYTH: Influenza Vaccines Are Not Effective − cont’d

• In addition, many vaccinated people think they “got the flu” when in reality, they had a cold or another viral infection. Influenza vaccines protect against infection caused by the influenza viruses selected for the season’s vaccine. • Flu vaccines will not protect against infection and illness caused by other viruses that can also cause influenza-like symptoms.

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References – Influenza

• IAC’s Influenza web section www.immunize.org/influenza • Flu Vaccine Effectiveness: Q&As for Health Professionals www.cdc.gov/flu/professionals/vaccination/effective nessqa.htm • Vaccine Effectiveness—How Well Does the Flu Vaccine Work? Q&As for the Public www.cdc.gov/flu/about/qa/vaccineeffect.htm • Public health groups say flu vaccine is best tool, despite limitations www.cidrap.umn.edu/news- perspective/2011/10/public-health-groups-say-flu- vaccine- best-tool-despite-limitations

MYTH: Mandatory Vaccination Violates Civil Rights

• Massachusetts enacted the first mandatory vaccination law in the U.S. in 1809. • Vaccination laws have been found to be constitutional in U.S. courts. Seminal case was Jacobson v. Massachusetts in 1905. • All states offer medical exemptions, 48 allow religious exemptions, and 20 allow philosophical exemptions. • Parents need to be aware that if they don’t vaccinate their children, they are putting them, and their contacts, at risk of serious disease. • Unvaccinated children often have to stay home from school or daycare during outbreaks.

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References

• IAC’s “What if you don’t immunize your child?” www.immunize.org/catg.d/p4017.pdf • IAC’s “Decision to Not Vaccinate My Child” (declination form) www.immunize.org/catg.d/p4059.pdf • “Personal belief exemptions for vaccination put people at risk” www.immunize.org/catg.d/p2069.pdf • AAP’s “Refusal to Vaccinate” form www.aap.org/immunization/pediatricians/pdf/RefusaltoVaccin ate.pdf • All Star Pediatric’s sample vaccine policy statement www.immunize.org/aap/pediatrics_vaccine_letter.pdf • VaccineEthics.org – University of Pennsylvania www.vaccineethics.org/issue_briefs/requirements.php

MYTH: Abortions Are Required to Produce Vaccines

• It’s true that production of varicella, rubella, rabies, and hepatitis A vaccines involves growing viruses in human cell culture. • Two human cell lines provide these cultures; they were developed from two legally aborted fetuses in the 1960s. • The donor fetuses were not aborted for the purpose of obtaining these cells. • The same cell lines have been used for 35 years — no new fetal tissue is required.

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References

• IAC’s web page about ethical and religious objections to vaccination www.immunize.org/concerns/religious.asp • NNii’s “Human Fetal Links with Some Vaccines” www.immunizationinfo.org/issues/vaccine- components/human-fetal-links-some-vaccines

MYTH: VAERS Data Prove that Vaccines Are Dangerous

• VAERS data cannot “prove” anything: • Anyone can report anything... no proof of causality is required. • Only reports of special interest (e.g., hospitalizations) are verified. When checked, many reports are not accurate. • Reports include many non-serious reactions. • The number of reported adverse events is influenced • by publicity. • VAERS is properly used to detect early warning signals and generate hypotheses.

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Don’t Worry About Every Possible Question

• Be able to recommend good websites and handouts for patients/parents. • Be aware of major vaccine-critical groups and individuals and become familiar with their websites. • Be ready to answer the most common questions — many concerns haven’t changed in over 200 years! • Remember, it’s acceptable to say you’ll look into a question and get back to the patient with more information. • It’s worth your time — people respect the opinion of their healthcare providers.

Good Resources for Patients

• IAC’s Talking About Vaccines www.immunize.org/concerns • VEC’s handouts on hepatitis A, meningococcal, HPV, influenza, shingles, and Tdap www.chop.edu/service/vaccine-education- center/order-educational-materials • National Foundation for Infectious Diseases www.adultvaccination.org • National Network for Immunization Information www.immunizationinfo.org • CDC’s web section for adults www.cdc.gov/vaccines/spec-grps/adults.htm

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Good Resources for Patients

• IAC’s “Vaccinations for Preteens and Teens, Age 11– 19 Years” www.immunize.org/catg.d/p4020.pdf • IAC’s “Vaccinations for Adults” www.immunize.org/catg.d/p4030.pdf • IAC’s website for the public www.vaccineinformation.org • VEC’s “Vaccines and Adults: A Lifetime of Health” www.chop.edu/export/download/pdfs/articles/vaccine - education-center/vaccines-adults.pdf • VEC’s “Vaccines and Teens: The Busy Social Years” www.chop.edu/export/download/pdfs/articles/vaccine - education-center/vaccines-and-teens.pdf

Provider Myths

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Provider Myths

• Vaccination contraindications and precautions are complicated, and the many new vaccines and their recommendations can cause confusion that leads to misconceptions. • Providers who are concerned about vaccinating properly frequently err on the side of caution. • Unfortunately, misconceptions can lead to missed opportunities to vaccinate.

Provider Myths

• MYTH – Vaccines can’t be given to people who are sick. • FACT – Mild acute illness with or without fever is not a contraindication to vaccination. Neither is antibiotic treatment, recent exposure to an infectious disease, or convalescing from an illness.

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Provider Myths

• MYTH – Certain vaccines can’t be given together. • FACT – All routine vaccines can be given simultaneously (at the same visit, not in the same syringe). If 2 live virus vaccines are not given at the same visit, then they need to be separated by at least 4 weeks. Inactivated vaccines can be given at the same time, or any time before or after, another inactivated or live vaccine.

Provider Myths

• MYTH – Providers need to check vital signs before vaccinating. • FACT – ACIP does not recommend routinely checking temperature or other vital signs before vaccination. Mild illness is not a reason to withhold vaccination and requiring extra steps can be a barrier to immunization.

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Provider Myths

• MYTH – Vaccines can’t be given to breastfeeding women. • FACT – All vaccines can be given to breastfeeding women except smallpox vaccine (yes, even live vaccines, even nasal-spray vaccines!).

Provider Myths

• MYTH – Live virus vaccines (zoster, varicella, MMR, and LAIV) should not be given to contacts of pregnant women or to contacts of immunocompromised people. • FACT – False. The only concern would be in the rare instance when a person develops a varicella-like rash after receiving varicella or zoster vaccine. Then the vaccinee should avoid close contact with the unvaccinated infant or immuno- compromised person until the rash resolves.

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Provider Myths

• MYTH – Tdap can’t be given if a person has received Td in the last 5 years. • FACT – There is no "minimum interval" one needs to wait between receiving Td and Tdap. If necessary, it can be given the same day.

Provider Myths

• MYTH – Pregnant women should never get vaccines. • FACT – Although pregnant women should not receive LIVE vaccines, influenza and Tdap are recommended in pregnancy. Other inactivated vaccines may or may not be administered, depending on the mother’s risk factors and vaccination status. HPV vaccine has not been sufficiently studied so should not be administered during pregnancy at this time.

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Provider Myths

• MYTH – Pregnant women and infants need to get thimerosal-free influenza vaccine. • FACT – There is no scientific evidence that thimerosal in vaccines, including influenza vaccines, is a cause of adverse events, unless the patient has a systemic allergy to thimerosal. However, there are some states that have banned the use of influenza vaccines containing thimerosal

Background Resources for Providers

• IAC’s “ACIP Recommendations” web section www.immunize.org/acip • IAC’s “Ask the Experts” web section with CDC experts www.immunize.org/askexperts • IAC’s Vaccine Information Statement (VIS) web section www.immunize.org/vis • IAC’s Immunization Education Materials web section www.immunize.org/handouts • IAC’s “Summary of Recommendations for Adult Immunization” www.immunize.org/catg.d/p2011.pdf • IAC’s Pharmacist and Immunization web section www.immunize.org/pharmacists

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Background Resources for Providers

• ACIP's “General Recommendations on Immunization” www.cdc.gov/mmwr/PDF/rr/rr5515.pdf • CDC's “Pink Book” www.cdc.gov/vaccines/pubs/pinkbook/index.html • CDC’s “Guide to Vaccine Contraindications and Precautions” www.cdc.gov/vaccines/recs/vac-admin/ contraindications.htm • CDC’s “Immunization & Pregnancy” www.cdc.gov/vaccines/pubs/downloads/ f_preg.pdf

Questions?

27 Understanding the Advisory Committee on Immunization Practices (ACIP) recent recommendations

Stan Grogg, DO Professor Emeritus, Oklahoma State University-CHS AOA’s Liaison member of ACIP

Potential Conflicts of Interest

Speaker’s Bureaus Consultant • Sanofi-Pasteur • Novartis for • Novartis meningitis • MedImmune • for meningococcal meningitis type B • Merck for HPV

1 After the presentation, participants should be able • 1. Understand the evidenced-based facts concerning vaccine myths (Dr. Bell) • 2. Apply the truths of immunization myths when communicating with their patients. (Dr. Bell) • 3. Describe recent ACIP vaccine recommendations (Dr. Grogg) • 4. Counsel their patients concerning the most current ACIP immunization updates (Dr. Grogg)

Who composes the ACIP? • The Advisory Committee on Immunization Practices (ACIP) – Group of medical and public health experts – Develops recommendations on how to use vaccines to control diseases in the United States – Recommendations stand as public health • Lead to a reduction in the incidence of vaccine preventable diseases • Increase in the safe use of vaccines and related biological products.

2 ACIP consists of 15 experts (voting members) • Responsible for making vaccine recommendations • 14 members have expertise in vaccinology, immunology, pediatrics, internal medicine, nursing, family medicine, virology, public health, infectious diseases, and/or preventive medicine • 1 member is a consumer representative who provides perspectives on the social and community aspects of vaccination.

ACIP other participants • 8 ex officio members who represent other federal agencies with responsibility for immunization programs in the United States • 30 non-voting representatives of liaison organizations that bring related immunization

expertise (Such as the AOA) m e

• For more information, visit: http://www.cdc.gov/vaccines/acip/about.html

3 What smartphone vaccine App is best for keeping up with recommendations? • The CDC Vaccine app for smart phones – Free – All of the immunization schedules for children, adolescents and adults including special indications – Contradictions/precautions

So let’s discuss some of the recent recommendations • HPV • Flu Vaccine 2014-15 • Pneumococcal • Herpes Zoster • Immunosuppressed patients • Hep A • Meningococcal B • Refrigeration of vaccines 1. http://www.immunize.org/nt/ 2. http://www.cdc.gov/vaccines/acip/recs/

4 HPV Vaccine • Good news: – New study finds no safety concerns with inadvertent HPV vaccination during pregnancy • FDA approved 9 for prevention of certain cancers caused by five additional types of HPV. (Dec. 10, 2014) • ACIP recommendations to follow after Feb. 2015 ACIP meeting.

Gardasil 9 (Merck) • Vaccine approved for use in females ages 9 through 26 and males ages 9 through 15. • Approved for… – Prevention of cervical, vulvar, vaginal and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58 – Prevention of genital warts caused by HPV types 6 or 11 – Adds protection against five additional HPV types—31, 33, 45, 52 and 58— which cause approximately 20 percent of cervical cancers

5 What You Should Know for the 2014-2015 Influenza Season • “Drift” and “Shift” of influenza virus – Drift, less serious that shift:

US Health Agency (Reuters 12/3/2014) • Issued an advisory to doctors noting that flu virus samples the agency took from Oct. 1 through Nov. 22, showed that just under half were a good match for the current influenza A (H3N2), suggesting the virus has drifted (< 50% effective). • The BAD news: Influenza A (H3N2) strains tend to have higher overall hospitalization rates and more flu-related deaths, especially among older people and very young children – –Remember 50% effective is better than 0%!

6 Drifted H3N2 viruses aren’t precisely matched cont’d

• Even when there is a less than optimal match or lower effectiveness against one virus, it is important to remember that influenza vaccine contains three or four influenza virus strains, depending on the vaccine – B influenza viruses and H1N1 are circulating, as well as the A/H3N2 viruses.

Clinical question: so, the drifted H3N2 viruses aren’t precisely matched

• An office offers the quadrivalent inactivated influenza vaccine/ Will it protect their patients against the drifted H3N2 influenza virus? – Antibodies made in response to vaccination with one influenza virus may provide some protection against different but related viruses – A less than optimal match may result in reduced vaccine effectiveness but it can still provide some protection against influenza illness.

7 FDA approves quadrivalent formulation of Fluzone Intradermal inactivated influenza vaccine • December 11, 2014: approval of a quadrivalent Fluzone Intradermal, inactivated influenza vaccine (). • Now available in a quadrivalent formulation to help protect against four strains of influenza vaccine (adults 18 through 64) .

Use of 13-Valent Pneumococcal (PCV23) and 23-Valent Pneumococcal Polysaccharide Vaccine (PPV- 23) Among Adults Aged ≥65 Years

• CDC recommended all adults age 65 years and older receive both pneumococcal conjugate vaccine (PCV13, Prevnar 13, Pfizer) and pneumococcal polysaccharide vaccine (PPSV23, Pneumovax, Merck).

8 PCV13 and PPSV23 for 65 and older cont’d • Should both the PCV13 and PPSV23 vaccine be given at the same visit for people age 65 and older? – Yes – No • Although both PCV13 (Prevnar 13) and PPSV23 (Pneumovax) are both recommended routinely in a series to all adults age 65 and older, the two vaccines should NOT be given at the same visit. – Decreases PPSV23 vaccine efficacy

Pneumococcal vaccine naïve persons • Give PCV13 first, followed by PPSV23 six – 12 months later • If the PPSV23 dose cannot be administered during this time window, the PPSV23 dose should be given at the next visit. • If the doses of PCV13 and PPSV23 are administered at an interval less than 6-12 months apart, the minimum acceptable interval between the two doses is 8 weeks (which means that PPSV23 should be repeated if given earlier than 8 weeks after PCV13))

9 Pts. with previous vaccination with PPSV23 • Adults 65 and older who have previously received one or more doses of PPSV23, should receive a dose of PCV13 if they have not year received it. • A dose of PCV13 should be given at least 1 year after receipt of the most recent PPSV23 dose • For those in whom an additional dose of PPSV23 is indicated, this subsequent PPSV23 dose should be given 6-12 months after PCV13 and at least 5 years after the most recent dose of PPSV23.

Confusing?; Let’s review a case • A 65 y/o man with a cochlear implant at 62 years of age, received a PPSV23 just prior to the procedure. • Now at age 65, should he receive a PCV13? – Yes – No • Since he is over 65, should he receive both the PCV13 and PPSV23 today? – Yes – No • Do not give both PCV13 and PPSV23 at same visit and PPSV23 should be 5 years after last dose (PPSV23 at 67)

10 Is PPSV23 indicated for smokers? • Yes • No • Pneumococcal polysaccharide vaccine is currently recommended for people age 19-64 years who actively smoke. • For former smokers, chronic lung disease is an indication for PPSV23.

Herpes Zoster Vaccine is approved by FDA for 50 and older but…. • ACIP recommends that clinicians vaccinate people 60 and older; WHY? – Burden of HZ disease increases after age 50, but disease rates are lower in this age group than they are in persons age 60 years and older – Insufficient evidence for long term protection provided by the vaccine – Persons vaccinated at younger than age 60 years may not be protected when the incidence of zoster and its complications are highest.

11 Herpes Zoster Vaccine (Zostavax by Merck) • How effective is zoster vaccine in preventing shingles? – 51% reduction in shingles – Less severe illness when shingles did occur compared with placebo recipients • Will administering zoster vaccine prevent post- herpetic neuralgia (PHN)? – Yes • 66.5% effective in preventing PHN • Lessens the severity of both shingles and PHN if a person should develop zoster after vaccination N Eng J Med 2005;352:2271-84)

Can immunosuppressed patients receive vaccines? • Yes, but only inactivated vaccines, not live vaccines (No MMR, Varicella or Yellow Fever) • The vaccines might not be as effective as they would be when given to a person with an intact immune system. • If possible, the immunosuppressive drug should be discontinued for a month prior to vaccination, then allow the vaccine 2-3 weeks to generate an immune response before restarting the immunosuppressive treatment.

12 Hepatitis A seems to be increasing again in US

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Hep A at risk persons

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13 Why is Hep A increasing? NO 2nd dose?

What is the incidence of the different serotypes of Meningococcal disease in US?

14 What about the recent outbreaks of Men B

Is there a Men B vaccine approved for young adults? • Yes: – Pfizer Receives FDA Accelerated Approval for TRUMENBA® (Meningococcal Group B Vaccine) for the Prevention of Invasive Meningococcal B Disease in Adolescents and Young Adults (Oct. 28, 2014) • to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. • ACIP has not presently made a recommendation concerning TRUMENBA

15 General storage question • If you store vaccine in the refrigerator of a two- compartment refrigerator/freezer, can you store staff food in the freezer portion? – Yes – No • CDC recommends using separate refrigerator and freezer units for , but still allows use of a combination refrigerator/freezer if you only use the refrigerator portion for storing vaccines. • CDC recommends you store food and beverages in a separate storage unit from vaccines.

Questions/Comments

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